Late last year we published the post “Twiqbal for Defendants? Not If We Can Help It.” on the issue of whether the “plausibility” standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S 662 (2009), applied to “affirmative defenses (which we prefer to just
Contrary to rumor, we are not on the verge of changing our name to the Filter Device Litigation blog. True, we are now on a several consecutive weeks run of sharing very good IVC opinions. In fact, we will likely have two this week. The recent outbreak of good sense largely emanates from Indiana, but
We’re blogging today because of an annoyance – another of these nuisance motions filed by plaintiffs that should be skirting the border of Rule 11, but unfortunately isn’t. Our particular gripe is a motion to strike a defendant’s pleaded defenses (please don’t call them “affirmative” defenses unless they really are) because they supposedly don’t meet
In medical device product liability cases to which preemption by reason of FDA pre-market approval (“PMA”) applies, courts have consistently misinterpreted the Supreme Court’s dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) − finding the plaintiff’s “parallel” violation claims waived by failure to assert in the court of appeals – as somehow
It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest
At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments. Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts. Sometimes, the trial court decisions are unpublished but interesting, and
This post is from the non-Reed Smith side of the blog.
“He who knows others is wise; he who knows himself is enlightened.” — Lao Tzu
This may not be exactly what the court in Moore v. C.R. Bard, Inc., 2016 U.S. Dist. LEXIS 156923 (E.D. Tenn. Nov. 14, 2016) had in mind when it authored its recent opinion dismissing the complaint in this case, but the decision brought these ancient philosophical words to our mind. Of course, if we are talking about self-knowledge advice, we might be more partial to Ann Lander’s “Know yourself. Don’t accept your dog’s admiration as conclusive evidence that you are wonderful.” But, we trust you get the point. You better know yourself first before you start worrying about what you don’t know about others.
Plaintiffs tend to put the cart before the horse on this issue. When faced with a motion to dismiss for failure to state a claim, plaintiffs focus intently on what they claim they don’t know yet or can’t possibly know – but never seem interested in all of the things that they should know before filing a lawsuit. That’s a big part of where plaintiffs fell short in Moore.
During surgery to repair a hernia, two mesh products were implanted in plaintiff – one Bard product and one Ethicon product. Id. at *2-3. Plaintiff alleged that both products were made of polypropylene; that both defendants failed to adequately warn about the risks of their products; and that following surgery plaintiff’s condition worsened which he alleges is due to one or both of the mesh products. Id. at *3-4. And, that is all plaintiff alleged.
Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean: the spider-like creatures with small centers, from which long, bent legs emanate in all directions. That is sort of what IVC filters look like, although any resemblance ends there. Manufactured from thin flexible metal, IVC filters can be implanted in the big vein that returns deoxygenated blood to your heart—the vena cava—to trap clots (or anything else) and prevent them from traveling to your heart and lungs, where they can cause serious mischief. They are potentially life-saving devices. They last came to our attention the other day when we received a robotic phone call asking us if we knew anyone with an IVC filter who might want to sue. Ye gods.
An order granting a motion to dismiss in an IVC filter case crossed our desks this week, and its discipline and thoroughness caught our eye. The case is Dunson v. Cordis Corp., No. 16-06-03076, 2016 U.S. Dist. LEXIS 94873 (N.D. Cal. July 20, 2016). The complaint in Dunson included the claims of six different plaintiffs whose claims appear to be unrelated, except that they have the same lawyers and were treated with similar filters made by the same manufacturer. Id. at **3-4. They all alleged complications from filter implantation, and they alleged the full range of product liability claims. Only the express warranty claim survived, and here is why:
Strict liability for design defect: Guess what. The plaintiffs sued in California, and California does not permit strict liability design defect claims in prescription medical device cases. Plaintiffs tried to get around this by asserting in their opposition, for the first time, that some of them had their filters implanted in Arizona and Pennsylvania and that those states’ laws therefore should apply. Id. at **9-12. This position raises so many questions: If they were treated outside California, do they also reside outside California? If so, why are Pennsylvania and Arizona residents suing a Florida corporation with an Ohio headquarters in California’s courts? If they are from out of state, why did they conceal those facts and wait until opposing a motion to dismiss to admit them? The answers are that these are forum-shopping plaintiffs who are importing their claims along with hundreds of others into California for no legitimate purpose. Their choice-of-law argument did not work this time around. The district court still dismissed their design defect claim, and it admonished the out-of-state plaintiffs to allege facts in their amended complaint to support their choice of law. Id. at **12-13. The court was “skeptical.”
In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee. Downtown Memphis had not yet undergone “gentrification,” so a short walk in any direction from the Federal Building had to be undertaken with some caution. In addition to barbecue and blues, a federal litigant’s visit to Memphis held the prospect of appearing before any one of an interesting assemblage of district judges. Judge Odell Horton had taken senior status after a long stint as chief judge of the district; he was a Carter appointee and exceedingly nice to everyone. He was also the first African American federal judge in Tennessee since Reconstruction. Judge Julia Smith Gibbons had taken over as the chief judge after starting on the federal bench at 33—a Reagan appointee—and everyone knew she would be heading up to the Sixth Circuit at some point. Judge Jerome Turner was another Reagan appointee, who we recall mostly for taking his clerks to lunch regularly and for an untimely death a few years later. Judge Bernice Donald assumed the bench while we were there, having been tapped to jump up from the bankruptcy court by the first President Clinton. (The actor/Senator who was in Die Hard 2: Die Harder showed up for the swearing in ceremony.) Judge McCalla had been appointed by the first President Bush and clerked (for Judge Bailey Brown, before he went up to the Sixth Circuit) in the same chambers some years earlier. He had the military bearing you would expect from his pre-law background as an office in Vietnam and a well-deserved reputation for being “by the book” and “no nonsense.” (The softer side that attorneys appearing before him missed was evident when he was with his family, including the puppy we helped train while housesitting.)
Twenty years later, we discuss Judge McCalla’s decision in Fleming v. Janssen Pharms., Inc., No. 2:15-cv-02799-JPM-dkv, 2016 WL 3180299 (W.D. Tenn. June 6, 2016), which follows the memorable Yates decision authored by Judge Gibbons, who did, indeed, head up to the Sixth Circuit. Hence why we recounted the iudicis personae of the Western District from our relative youth. Fleming involves asserted state law claims in connection with plaintiff’s alleged kidney injuries from a branded prescription diabetes drug. Defendants moved to dismiss on various grounds, which we will discuss in the order of importance to us.
First, of course, was the argument that plaintiff’s design defect claim was preempted as pleaded. This angle of attack is noteworthy because winning any kind of preemption for a branded prescription drug at the motion to dismiss phase is rare and because the progression from Bartlett to Yates (decided on summary judgment) to such motions being viable was something we forecast/urged. As discussed more later, plaintiff had pretty barebones design defect allegations that suggested that all drugs within this class of anti-diabetic agents was too risky and that there were “several safer alternative products”—not alternative designs for this product. Id. at *1. In response to defendant’s argument for impossibility preemption, plaintiff contended that its claim was based on a “duty to design the drug differently before FDA approval,” which could have been characterized as “never start selling theory.” Id. at *5. “The Sixth Circuit, however, found this type of argument to be ‘too attenuated’ and ‘speculat[ive]’ because it requires several assumptions as to FDA approval and a patient’s selections of and medical reaction to the alternative design.” Id. (quoting Yates, 808 F.3d 281, 199-300). While a case with the same drug in the Eleventh Circuit had rejected Yates impossibility preemption while granting a motion to dismiss, the analysis in Fleming was straightforward. “The Court finds that Plaintiffs’ design defect claims are preempted by federal law because preemption can apply to both generic and branded drugs and because it would have been impossible for Defendants to comply with both state and federal law.” Id. Like we said, this is a “by the book” judge. Other judges taking a similar approach could provide the advantage of getting obviously preempted design defect claims out early, narrowing the scope of fact and expert discovery.
In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly descriptor of ethnically ambiguous looking people, whose roots have been mashed together to form something not readily identifiable by traditional visual stereotypes. (At least it seemed friendly when we heard it applied to our own offspring.) Personally, we think it is a nice concept and the less that categorizing people to determine their rights, opportunities, and expectations happens, the better. For a number of aspects of product liability law, however, the decision on whether to proceed categorically or case-by-case is still hotly contested. This is particularly true for comment k to the Restatement (Second) of Torts, § 402A, which forms the meat of the decision in Segovia v. Bristol-Myers Squibb Co., CV. No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).
Segovia involves a fatal hemorrhagic stroke with an anticoagulant prescribed and used for atrial fibrillation. We are not sure what was different from the first complaint, but the second try made vague allegations about misrepresentations to FDA and others that it was “tested and found to be safe and effective for its indicated uses” and that FDA and others had not been told of the drug’s “defects” in support of allegations of strict liability and negligent failure to warn and design defect theories. While it seems like this complaint asserted claims based on non-existent duties and clearly preempted claims, the only issues addressed by the court on the motion to dismiss were whether Hawaii law took comment k to preclude design defect claims for all prescription drugs categorically and whether any fraud-based claims had been pleaded with sufficient particularity.
As to the first question, the court did not look to our relatively recent discussions on this issue, but generally looked to older cases to find the public policy rationale for taking a case-by-case approach for prescription drugs—which was essentially determinative on a motion to dismiss. But we are getting ahead of ourselves. The first step was determining what Hawaii case law already said about comment k and only two cases were discussed. Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded that summary judgment based on comment k was inappropriate where there was evidence that the “pacemaker was demonstrably capable of being made safe for its intended use.” Forsyth v. Eli Lilly & Co., 1998 WL 35152135, **3-4 (D. Haw. Jan. 5, 1998), involved a prescription drug, but did not decide the issue of categorical or case-by-case because a genuine issue as to the adequacy of warnings was sufficient to preclude summary judgment. Rather than view these cases are leaving the issue open, the Segovia court found “neither Larsen nor Forsythe create a blanket rule of design defect immunity for pharmaceutical manufacturers, and the Court declines to extend comment k in a fashion that the Hawaii courts themselves have thus far declined to do.” 2016 U.S. Dist. LEXIS 52405, *11. We think this misconstrues comment k, which does not provide “immunity,” and what it means to conclude that all prescription drugs are “unavoidably unsafe.”